Cultured cell leaflet material

Abstract

A prosthetic heart valve provided herein can include a cultured cell tissue leaflet. In some cases, a prosthetic heart valve can include a plurality of leaflets secured together and retained within the expandable tubular member. The cultured cell tissue can be obtained by culturing fibroblast cells, smooth muscle cells, or a combination thereof to form a sheet of cultured cells and chemically cross-linking the fibroblast cells while under tension. In some cases, the cultured cell tissue can be radially tensioned. In some cases, the cultured cell tissue can be bi-axially tensioned.

What is claimed is: 
     
       1. A prosthetic heart valve comprising
 a plurality of leaflets secured together and retained within an expandable tubular member, the leaflets comprising radially or biaxially tensioned and chemically cross-linked cultured cell tissue; 
 wherein the radially or biaxially tensioned cultured cell tissue has been chemically cross-linked while under tension to prevent recoil of the cultured cell tissue after the tension is released; and 
 wherein the cultured cell tissue leaflets have a percentage of elongation at 500 kPa of between 6.5% and 8.5%. 
 
     
     
       2. The prosthetic heart valve of  claim 1 , wherein the cultured cell tissue is cultured from fibroblast cells. 
     
     
       3. The prosthetic heart valve of  claim 2 , wherein the fibroblast cells are dermal fibroblast cells. 
     
     
       4. The prosthetic heart valve of  claim 3 , wherein the dermal fibroblast cells are bovine dermal fibroblast cells. 
     
     
       5. The prosthetic heart valve of  claim 1 , wherein the cultured cell tissue is cultured from cells including smooth muscle cells. 
     
     
       6. The prosthetic heart valve of  claim 5 , wherein the smooth muscle cells are bovine smooth muscle cells. 
     
     
       7. The prosthetic heart valve of  claim 1 , wherein the cultured cell tissue is cultured from a mixture of fibroblasts and smooth muscle cells. 
     
     
       8. The prosthetic heart valve of  claim 7 , wherein the fibroblast cells and smooth muscle cells are in a ratio of between 20:80 and 80:20. 
     
     
       9. The prosthetic heart valve of  claim 1 , wherein the cultured cell tissue is cross-linked with glutaraldehyde. 
     
     
       10. The prosthetic heart valve of  claim 1 , wherein the cultured cell tissue is cultured for at least 3 weeks. 
     
     
       11. The prosthetic heart valve of  claim 10 , wherein cultured cell tissue is cultured for at least 5 weeks. 
     
     
       12. The prosthetic heart valve of  claim 1 , wherein the cultured cell tissue has a thickness of between 50 micrometers and 300 micrometers. 
     
     
       13. The prosthetic heart valve of  claim 1 , wherein the cultured cell tissue leaflets have a percentage of elongation at 1 MPa of between 10.5% and 13.5%. 
     
     
       14. The prosthetic heart valve of  claim 1 , wherein the cultured cell tissue leaflets have an ultimate tensile strength of between 4 MPa and 6.5 MPa. 
     
     
       15. The prosthetic heart valve of  claim 1 , wherein the cultured cell tissue leaflets have a moisture content of between 80% and 88%. 
     
     
       16. The prosthetic heart valve of  claim 1 , wherein the cultured cell tissue leaflets consist of radially or biaxially oriented and fixed cultured cell tissue. 
     
     
       17. A prosthetic heart valve comprising
 a plurality of leaflets secured together and retained within an expandable tubular member, the leaflets comprising radially or biaxially tensioned and chemically cross-linked cultured cell tissue; 
 wherein the radially or biaxially tensioned cultured cell tissue has been chemically cross-linked while under tension to prevent recoil of the cultured cell tissue after the tension is released; and 
 wherein the cultured cell tissue leaflets have a shrinkage temperature of between 83.8° C. and 84.6° C. 
 
     
     
       18. A prosthetic heart valve comprising
 a plurality of leaflets secured together and retained within an expandable tubular member, the leaflets comprising radially or biaxially tensioned and chemically cross-linked cultured cell tissue; 
 wherein the radially or biaxially tensioned cultured cell tissue has been chemically cross-linked while under tension to prevent recoil of the cultured cell tissue after the tension is released; and 
 the leaflets comprising tissue-only cultured cell tissue excluding exogenous biomaterial scaffolds.